Evaluation of Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism (STEM-PARK)

Biocells Medical

Status and phase: Begins enrollment in 7 months; Phase 2

Conditions: Parkinsonism in Diseases Classified Elsewhere; Parkinsonism or Parkinson's Disease Nos

Treatments: Biological: Intravenous; Biological: Intrathecal (IT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07471230

Bio120007

Details and patient eligibility

About

This clinical trial investigates the safety and therapeutic potential of mesenchymal stem cell-based therapies in patients with parkinsonism.

The study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell-derived exosomes as potential regenerative treatments targeting neurodegeneration within dopaminergic pathways.

Enrollment: 120 estimated patients

Sex: All

Ages: 48 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age 40-80 years Clinical diagnosis of Parkinsonism Hoehn and Yahr stage II-III Stable pharmacological treatment for ≥3 months

Exclusion criteria

Atypical parkinsonian syndromes unrelated to neurodegeneration History of malignancy within 5 years Severe cardiovascular disease Prior cellular therapy Active infection or immunosuppression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Neuroinduced Mesenchymal Stem Cells

Experimental group

Description:

200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.

Treatment:

Biological: Intrathecal (IT)

Mesenchymal Stem Cell Derived Exosomes

Experimental group

Description:

1×10¹¹ particles per infusion

Treatment:

Biological: Intravenous

Intravenous saline infusion

Placebo Comparator group

Treatment:

Biological: Intravenous